Biosensor inserter apparatus and methods

ABSTRACT

A biosensor inserter includes a push member with a push element, a contact member including a latch, a transmitter carrier supporting a transmitter and sensor assembly, and a pivot member having a latch end, the pivot member supporting an insertion device during biosensor insertion. In operation, the push member is telescoped axially by the user relative to the contact member, which is provided in contact with a user&#39;s skin. This pushes the push element against the pivot member and translates the transmitter carrier during insertion of the biosensor. During a first portion of a stroke of the insertion device, insertion of the biosensor is accomplished, and the pivot member is prevented from pivoting. In a second portion of the stroke, after latch end moves past the latch, the pivot member is allowed to pivot and the insertion device is retracted. Other system and method embodiments are provided.

RELATED APPLICATIONS

This application is related to U.S. Provisional Application Ser. No.62/889,444 entitled “CONTINUOUS GLUCOSE MONITOR INSERTER APPARATUS ANDMETHODS” filed on Aug. 20, 2019, and U.S. Provisional Application Ser.No. 63/027,346 entitled “BIOSENSOR INSERTER APPARATUS AND METHODS” filedon May 19, 2020, each of which is hereby incorporated by referenceherein in its entirety for all purposes.

FIELD

The present disclosure relates to an inserter configured to insert abiosensor, which can be part of a continuous glucose monitor (CGM).

BACKGROUND

Continuous analyte sensing, such as with a continuous glucose monitor(CGM), has become a routine sensing operation, particularly in diabetescare. By providing real-time glucose monitoring that provides glucoseconcentrations over time, therapeutic actions, such as insulinintroduction, may be applied in a timely manner and the glycemiccondition may be better controlled.

During a CGM operation, a biosensor of a transmitter and sensor assemblyis inserted subcutaneously and continuously operated in an environmentsurrounded by tissue and interstitial fluid (ISF). The biosensorinserted under the skin provides a signal to a transmitter of thetransmitter and sensor assembly, and that signal can be indicative ofthe patient's blood glucose level. These measurements may be madeintermittently and automatically many times throughout the day (e.g.,every few minutes or at some other suitable interval).

The transmitter of the transmitter and sensor assembly is adhered to theouter surface of a user's skin, such as on the abdomen, on the back ofthe upper arm, or at another suitable location, while the biosensor isinserted through the skin so as to contact ISF. This skin insertionprocess may be referred to as “insertion.” Devices for carrying out thisinsertion may be referred to as “inserters.”

Inserter designs may be complicated and costly to manufacture.Accordingly, improved designs of inserter apparatus and methods ofoperating them are desired.

SUMMARY

In some embodiments, a biosensor inserter includes a push memberincluding a push element, a contact member translatable relative to thepush member, the contact member including a latch, a transmitter carriertranslatable relative to the contact member and configured to support atransmitter and sensor assembly during insertion of a biosensor, a pivotmember configured to pivot on the transmitter carrier, the pivot memberincluding a latch end, and an insertion device drivable by the pivotmember to insert the biosensor, wherein during insertion of thebiosensor in a first portion of a stroke, the pivot member is preventedfrom pivoting, and wherein when the latch end of the pivot member movespast the latch, the pivot member is allowed to pivot in a second portionof the stroke and retract the insertion device.

In further embodiments, a biosensor inserter configured to insert abiosensor of a continuous monitoring transmitter and sensor assembly isprovided. The biosensor inserter includes a push member having a rigidpush element and a first alignment feature; a contact member having alatch and a second alignment feature, the contact member configured totelescope within the push member; a transmitter carrier configured tosupport the continuous monitoring transmitter and sensor assembly duringinsertion of a biosensor; a pivot member configured to pivot relative tothe transmitter carrier, the pivot member including a latch end, and aninsertion device supported by the pivot member; and wherein the firstalignment feature of the push member is configured to interface with thesecond alignment feature of the contact member so as to align the latchend with the latch, and wherein the pivot member is configured to sliderelative to an internal guide feature of the contact member and thepivot member is prevented from pivoting in a first portion of a strokeduring insertion of the biosensor, and wherein when the latch end of thepivot member moves past the latch, the pivot member is allowed to pivotin a second portion of the stroke and retract the insertion deviceleaving the biosensor implanted.

In further embodiments, a method of using an inserter apparatus toinsert a biosensor is provided. The method includes providing thebiosensor inserter comprising: a push member including a push element, acontact member translatable relative to the push member, the contactmember including a latch, a transmitter carrier translatable relative tothe contact member and configured to support a transmitter and sensorassembly during insertion of the biosensor, a pivot member configured topivot on the transmitter carrier, the pivot member including a latchend, and an insertion device drivable by the pivot member; contactingthe contact member to a user's skin; pushing on the push member during afirst portion of a stroke to cause the push element to contact the pivotmember, translate the transmitter carrier, and insert the insertiondevice and biosensor through and into the user's skin, wherein the pivotmember is prevented from pivoting during the first portion of thestroke; and continuing to push the push member until delatching of thelatch end from the latch, wherein the pivot member is allowed to pivotduring a second portion of the stroke and retract the insertion devicewhile leaving the biosensor implanted.

Other features, aspects, and advantages of embodiments in accordancewith the present disclosure will become more fully apparent from thefollowing detailed description, the claims, and the accompanyingdrawings by illustrating a number of example embodiments. Variousembodiments in accordance with the present disclosure may also becapable of other and different applications, and its several details maybe modified in various respects, all without departing from the scope ofthe claims and their equivalents. Thus, the description is to beregarded as illustrative in nature, and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings are to be regarded as illustrative in nature, and not asrestrictive. The drawings are not necessarily drawn to scale. Likenumerals are used throughout the drawings to denote like elements.

FIG. 1A is a side-perspective view of a biosensor inserter in accordancewith one or more embodiments provided herein.

FIG. 1B is an underside-perspective view of a biosensor inserterincluding a needle cover in accordance with one or more embodimentsprovided herein.

FIG. 1C is an underside-perspective view of a biosensor inserter withthe needle cover removed exposing the inserter portion of the insertiondevice in accordance with one or more embodiments provided herein.

FIG. 1D is a cross-sectioned side perspective view of a biosensorinserter illustrating the various components and their interconnectionsin accordance with one or more embodiments provided herein.

FIG. 1E is a partially cross-sectioned side perspective view of abiosensor inserter illustrating the various components and a perspectiveview of the assembly of contact member and transmitter carrier inaccordance with one or more embodiments provided herein.

FIG. 1F is a partially exploded, partial perspective view of a biosensorinserter illustrating another view of the various components inaccordance with one or more embodiments provided herein.

FIG. 1G is a first side perspective view of a contact member of abiosensor inserter in accordance with one or more embodiments providedherein.

FIG. 1H is a second side perspective view of an opposite side of thecontact member of FIG. 1G in accordance with one or more embodimentsprovided herein.

FIG. 1I is a bottom plan view of a transmitter carrier of a biosensorinserter in accordance with one or more embodiments provided herein.

FIG. 1J is a cross-sectioned side view of a transmitter carrier of FIG.1I taken along section line 1J-1J in accordance with one or moreembodiments provided herein.

FIG. 1K is a perspective side view of a transmitter carrier of abiosensor inserter in accordance with one or more embodiments providedherein.

FIG. 1L is a perspective side view of an assembly of a contact memberand carrier assembly of a biosensor inserter in accordance with one ormore embodiments provided herein.

FIG. 1M is a perspective side view of a carrier assembly of a biosensorinserter in accordance with one or more embodiments provided herein.

FIG. 1N is a top plan view of a pivot member of a biosensor inserter inaccordance with one or more embodiments provided herein.

FIG. 1O is a cross-sectioned side view of a pivot member of FIG. 1Ntaken along section line 1O-1O in accordance with one or moreembodiments provided herein.

FIG. 1P is a perspective view of a pivot member in accordance with oneor more embodiments provided herein.

FIG. 1Q is a side plan view of a transmitter-insertion assemblyincluding a transmitter and sensor assembly with a coupled insertiondevice in accordance with one or more embodiments provided herein.

FIG. 1R is a perspective view of a transmitter-insertion assembly inaccordance with one or more embodiments provided herein.

FIG. 1S is a first side plan view of an insertion device in accordancewith one or more embodiments provided herein.

FIG. 1T is a second side plan view of an insertion device in accordancewith one or more embodiments provided herein.

FIG. 1U is a perspective side view of an insertion device illustrating arouting of a biosensor in accordance with one or more embodimentsprovided herein.

FIG. 1V is an enlarged partial cross-sectioned side view of an insertiondevice illustrating routing of a biosensor in accordance with one ormore embodiments provided herein.

FIGS. 2A-2F illustrates multiple side cross-sectional views of abiosensor inserter during various stages of a method of insertion of abiosensor in accordance with embodiments provided herein.

FIG. 3 illustrates a flowchart of a method of using a biosensor inserterto insert a biosensor in accordance with embodiments provided herein.

FIG. 4A is a top-perspective view of an alternative embodiment ofbiosensor inserter in accordance with the disclosure.

FIG. 4B is a bottom-perspective view of the biosensor inserter of FIG.4A with the transmitter and biosensor assembly removed for illustrationpurposes in accordance with the disclosure.

FIG. 5A is a bottom-perspective view of an alternative embodiment ofpush member and push element in accordance with one or more embodimentsof the disclosure.

FIG. 5B is a partial plan view of an alternative embodiment of pushelement including a T-shaped cross section in accordance with thedisclosure.

FIG. 5C is a front-perspective view of an alternate embodiment ofcontact member including a flange and fin supports in accordance withthe disclosure.

FIG. 6A is a front-perspective view of a portion of an alternativeembodiment of transmitter carrier including fins and closed guides inaccordance with the disclosure.

FIG. 6B is a front-perspective view of an alternative two-piecetransmitter carrier in accordance with the disclosure.

FIGS. 6C and 6D are front-perspective views of an embodiment of aninserter device and an insertion needle, respectively, in accordancewith the disclosure.

FIG. 7 is an exploded front perspective view of an alternativeembodiment of biosensor inserter in accordance with the disclosure.

DETAILED DESCRIPTION

In one or more embodiments described herein, a biosensor inserter isprovided that may be inexpensively manufactured. The biosensor inserteris configured to implant (insert) a biosensor into the skin of a person.For example, in some embodiments, the biosensor inserter may include atransmitter carrier that holds a transmitter and sensor assembly duringinsertion of the biosensor, and a push element that translates thetransmitter carrier toward a user's skin during a first portion of astroke of the biosensor inserter. In one or more embodiments, the pushelement may be formed from a rigid piece of material, which may beintegral with or rigidly coupled to the push member. The push elementmay be offset from a central axis of the biosensor inserter.

In some embodiments, a pivot member, which contacts and operativelydrives an insertion device of the biosensor inserter, is restrained frompivoting as the transmitter carrier translates toward a user's skinduring a first portion (insertion portion) of the stroke of thebiosensor inserter, but is allowed to pivot once de-latched after thebiosensor is implanted in a user's skin. Once delatched, the pivotmember may pivot in a second portion of the stroke of the biosensorinserter, which causes the retraction (retraction portion) of theinsertion device and leaves the biosensor inserted into the user's skin.Thus, the pivot member does not pivot in the first portion of thestroke.

These and other structural and functional features of embodiments of theinserter are described below with reference to FIGS. 1A-7.

FIGS. 1A-1C illustrates perspective views of a biosensor inserter 100 inaccordance with one or more embodiments provided herein. Biosensorinserter 100 includes a push member 102, which in the depictedembodiment, is shown as including two coupled pieces, namely a topportion 102T and a bottom portion 102B that are coupled together.Biosensor inserter 100 further includes a contact member 106 that istranslatable axially (along axial axis 105) relative to the push member102 in the direction shown by arrow 107. Thus, contact member 106 can bereceived axially within the push member 102 and may be telescopictherewith. Push member 102 is the portion contacted and pushed upon bythe user during biosensor insertion. Push member 102 may optionally beconstructed as one piece.

As best shown in FIGS. 1G and 1H, the contact member 106 includes anupper end 106U and a lower end 106L. Lower end 106L may contact a user'sskin 113 (FIGS. 2A-2F) during insertion and retraction of an insertiondevice 120 to implant a biosensor 150 (See FIGS. 2B and 2C) therein.Contact member 106 further includes a latch 109 (FIG. 1D), which is alatch surface (lower latch surface) that once passed by via motion of alatch end 117 (FIGS. 1L-1M) of the pivot member 116 (FIGS. 1N-1P) willallow a pivot member 116 to rotate (FIGS. 2D-2F), as will be describedfurther herein. Up until when the latch end 117 passes by the latch 109,the pivot member 116 is restrained from rotation. The latch 109 (FIG.1D) of the contact member 106 can be formed as part of avertically-extending cutout 106C (FIGS. 1A-1C), and latch 109 cancomprise a circumferentially-disposed surface of a width wider than thelatch end 117 of the pivot member 116. Vertically-extending cutout 106Cmay be open at the lower end 106L.

As shown in FIGS. 1A-1F, the push member 102 can include a top member102T and a bottom member 102B, wherein the bottom member 102B is coupledto the top member 102T as shown. Bottom member 102B can comprise asleeve shape and the top member 102T can comprise an inverted cup thatmay be receivable over the sleeve. In more detail, the inverted cupcomprises a top portion 121 (FIG. 1D), which can comprise a circularplanar surface, and an annular sleeve portion 102S. A push element 104(FIG. 1D-1E) extends downwardly from the push member 102 and includes acontact end 104C. The push element 104 is a rigid member and extendsdownwardly (as oriented) from the underside 121U of the top portion 121and is provided in contact with the pivot member 116.

As best shown in FIGS. 1A-1C and 1E, top member 102T and bottom member102B may be coupled together by any suitable means, such as by havingtwo or more spring tabs 108 each including an inward protuberance 108P(FIG. 1E) being seated in a retaining feature 108R, such as a slot orgroove formed in the bottom portion 102B. The inward protuberances 108Pfunctionally snap into and lock into the respective retaining features108R of the bottom member 102B to retain the two together as one piece.Optionally, however, the push member 102 could be molded as one piece insome embodiments. Furthermore, other means for allowing a snap-fitconnection of the top member 102T to the bottom member 102B or otherwisecoupling top member 102T and bottom member 102B may be used. In someembodiments, as shown in FIG. 1F, push member 102 can comprise a ramp128 proximate a lower end 102L thereof, and the contact member 106 caninclude an inward protuberance 142 such as a snap fitting hookconfigured to engage with the ramp 128 upon assembly. If multiple inwardprotuberances 108P are used, there may be a corresponding ramp 128 foreach.

In some embodiments, the push member 102 and/or contact member 106 maybe formed from a biodegradable and/or recyclable material (e.g., arecyclable plastic, a biodegradable paper product, bamboo, etc.). Inother embodiments, push member 102 and/or contact member 106 may beformed from one or more polymer materials such as, but not limited to,acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal,polyphthalamide (PPA), polysulfone, polyethersulfone,polyetheretherketone (peek), polypropylene, high-density polyethylene(HDPE), and low-density polyethelene (LDPE). Other suitable materialsmay be used for the push member 102 and/or contact member 106.

FIG. 1B illustrates a perspective underside view of the examplebiosensor inserter 100 in accordance with one or more embodimentsprovided herein. With reference to FIG. 1B, biosensor inserter 100 mayinclude a transmitter and sensor assembly 115 detachably mounted to atransmitter carrier 114 (see also FIGS. 1C and 1D), such as in recess118 (FIG. 1D). The transmitter carrier 114 is axially translatablerelative to the contact member 106 and configured to support thetransmitter and sensor assembly 115 during insertion of a biosensor 150(FIGS. 1U, 1V, and 2A-2D). In particular, the transmitter and sensorassembly 115 may include transmitter electronics, a power source, and asensor assembly that includes biosensor 150. Thus, the transmitter andsensor assembly 115 is supported during insertion of the biosensor 150.

In some embodiments, the transmitter and sensor assembly 115 may includea base that supports transmitter electronics, a power source (e.g., oneor more batteries), and a sensor assembly (e.g., a biosensor such as ananalyte sensor for determining the concentration of one or moreanalytes). Example transmitter electronics may include an analog frontend for biasing an analyte sensor and for sensing current that passesthrough the biosensor 150, such as operational amplifiers, currentsensing circuitry, etc. Other transmitter circuitry may includeprocessing circuitry such as analog-to-digital converters for digitizingcurrent signals, memory for storing digitized current signals, acontroller such as a microprocessor, microcontroller or the like forpossibly computing analyte concentration values based on measuredcurrent signals, and transmitter circuitry for transmitting analyteconcentration values to an external device (e.g., a smart phone oranother suitable external device for storing and/or displaying analyteconcentrations). In some embodiments, the transmitter electronics mayform a separate transmitter unit, which may be reusable and that coupleswith a sensor unit of a base unit having the power source and sensorassembly. The base unit may be disposable. In such embodiments, thetransmitter electronics may be attached to the base unit before or afterthe biosensor 150 is inserted using the biosensor inserter 100.

In some embodiments, the sensor (e.g., biosensor 150) used within thetransmitter and sensor assembly 115 may include two electrodes and thebias voltage may be applied across the pair of electrodes. In suchcases, current may be measured through the sensor. In other embodiments,the sensor may include three electrodes such as a working electrode, acounter electrode, and a reference electrode. In such cases, the biasvoltage may be applied between the working electrode and the referenceelectrode, and current may be measured through the working electrode,for example. The sensor may include an active region including one ormore chemicals that undergo an analyte-enzyme reaction with the productsthey detect. The enzyme is immobilized on one or more electrodes toprovide a reaction (e.g., redox reaction) with the analyte and generatea current at the electrodes. For example, the reaction may affect theconcentration of charge carriers and the time-dependent impedance of thesensor. Example chemicals include glucose oxidase, glucosedehydrogenase, or the like. In some embodiments, a mediator such asferricyanide or ferrocene may be employed at the active region. In oneor more embodiments, a sensor may include a microneedle or a pluralityof microneedles, such as a microneedle array. In general, analytes thatmay be detected and/or monitored with a suitable sensor include glucose,cholesterol, lactate, uric acid, alcohol, or the like. An analyte isdefined herein as a component, substance, chemical species, or chemicalconstituent that is measurable in an analytical procedure.

An example biosensor 150 (FIG. 1U) can be any suitable implantablesensor that can be implanted in the skin 113 (FIG. 2A) of a user, suchas a strand-shaped sensor that is able to be received inside of theinsertion portion 120I of the insertion device 120 and that is able tosense an analyte concentration reading of an interstitial fluid underthe skin 113, such as a glucose sensor, lactate sensor, or the like.

As shown in FIGS. 1Q and 1R, in some embodiments, atransmitter-insertion assembly 119 that is an assembly of the insertiondevice 120 (shown in FIG. 1S through 1V) and the transmitter and sensorassembly 115 is provided. The transmitter-insertion assembly 119 caninclude a needle cover 124, which can be removed by the user prior tocarrying out the insertion method. The needle cover 124 is detachablefrom the insertion device 120 and shields the insertion portion 120I(e.g., needle portion) of the insertion device 120. Thus, the needlecover 124 is detachable from threads or other snap-fit features 120Tformed on the body 120B of the insertion device 120. Otherconfigurations of the needle cover 124 may be used.

As described, biosensor inserter 100 further includes a pivot member 116that is configured to pivot on and relative to the transmitter carrier114. Pivot member 116, as best shown in FIGS. 1N through 1P, includes alatch end 117 on a first end and may include an insertion device supportfeature 139 on an end opposite the first end. The insertion devicesupport feature 139 is configured to contact, support, and drive (insertand retract) the insertion device 120 during the insertion method.

In some embodiments, the insertion device support feature 139 comprisesa fork 139F configured to receive legs 120L of a body 120B of theinsertion device 120 (See FIGS. 1Q-1U) therein. Fork 139F can comprise afirst extending slot, which may extend fully through the lateral widthof the pivot member 116 and may have an open end on the end oppositefrom the latch end 117 of the pivot member 116, thus forming the fork139F. Upper prong 139FU and lower prong 139FL of the fork 139F may beconfigured to receive legs 120L of a body 120B there between. A stem120S (FIGS. 1S-1U) of the body 120B, from which the legs 120L laterallyextend, may be received in and through a vertical clearance 139C (FIGS.1N-1P). A second extending slot can extend vertically through at leastthe lower fork member 139FL to intersect with the laterally-extendingslot and form the vertical clearance 139C. The slots can be sized toreceive the legs 120L and stem 120S of the body portion 120B of theinsertion device 120. Upper and lower as used herein refer to theorientation shown in FIG. 2B, but it should be recognized that the pivotmember 116 and other elements may be oriented in other orientations whenin use.

Pivot member 116 may also include one or more pivot features that allowthe pivot member 116 to pivot relative to the transmitter carrier 114.For example, pivot member 116 may include laterally-extending features125 (e.g., posts) that interface with holes 127 in first and second sidesupports 135 and 136 of transmitter carrier 114 (see FIG. 1K) to form apivot axis 125A. Thus, the pivot member 116 is pivotable about the pivotaxis 125A and pivots on the transmitter carrier 114

A pivot location of the pivot member 116 can be formed between the firstend and the opposite end of pivot member 116. For example, pivot axis125A (FIG. 1N) may be formed by laterally-extending features 125, suchas cylindrical post extensions, that project from the respective lateralsides of the body of the pivot member 116. The laterally-extendingfeatures 125 can be received in the holes 127 (FIGS. 1J-1M) formed inopposite side supports 135, 136 of the transmitter carrier 114. Thepivot member 116 can include a push element interface feature 140, whichmay comprise a pocket or other interface feature formed between thepivot axis 125A and the latch end 117 that is configured to interfacewith and contact a contact end 104C (FIG. 1D) of the push element 104.Other suitable laterally-extending features may be used to form thepivot. Other pivot mechanisms may be used, such as a removable axle, orthe like.

In some embodiments, transmitter carrier 114 and/or pivot member 116 maybe formed from a plastic material such as, but not limited to,acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal,polyphthalamide (PPA), polysulfone, polyethersulfone,polyetheretherketone (peek), polypropylene, high-density polyethylene(HDPE), and low-density polyethelene (LDPE). Other materials may be usedfor transmitter carrier 114 and/or pivot member 116.

In operation, insertion device 120 is drivable by being contacted by thepivot member 116 in an insertion stroke to insert the biosensor 150 intothe user's skin 113 as shown in FIGS. 2B and 2C. The insertion device120 is drivable by the legs 120L of the body 120B being received in thefork 139F of the pivot member 116. Further, the legs 120L may eachinclude rectangular portions at their respective outer ends that arereceived in guides 135G, 136G (FIG. 1M) of transmitter carrier 114,which can be vertically oriented slots, and which may be open at the topend. The fit of the rectangular portions and the guides 135G, 136G maybe a slip fit, which can aid in restraining rotation of the insertiondevice 120 during insertion. Thus, guides 135G, 136G and rectangularends on legs 120L may interface and provide an anti-rotation supportalong an axis passing laterally through the legs 120L. Transmittercarrier 114 may further include a convex alignment member 138V (FIG. 1I,1K, and 1M), such as a vertically-extending rib (e.g., rounded ribshown), that is configured to interface with a concave alignment member138C of contact member 106, such as recess shown in FIG. 1L.

As best shown in FIGS. 1D and 1E, contact member 106 may be configuredto be concentric with push member 102 and may be telescopic therewith.In some embodiments, push member 102 may include a first alignmentfeature 122 (See FIG. 1E and FIG. 2A) such as a vertically-extendinggroove or recess, and contact member 106 may include a second alignmentfeature 123 (FIG. 2A), such as a vertically extending rib, thatinterfaces with the first alignment feature 122. Such alignment features122, 123 may hold push member 102 and contact member 106 in rotationalalignment to prevent rotation of the contact member 106 within the pushmember 102, such as during the insertion and retraction portions of thestroke. Push member 102 and contact member 106 may be cylindrical, oval,oblong, elliptical, or any other suitable shape in transversecross-section. In some embodiments, push member 102 and contact member106 may not be concentric.

In more detail, transmitter carrier 114 shown in FIG. 1I-1M isconfigured to support the transmitter and sensor assembly 115 duringinsertion of the biosensor 150 of the transmitter and sensor assembly115. Transmitter carrier 114 may be sized to fit within contact member106 as shown in FIG. 1L, which shows an assembly 141 of contact member106, transmitter carrier 114, pivot member 116, and insertion device120.

As best shown in FIG. 1A-1E, in some embodiments, contact member 106 mayinclude a first pre-insertion lock feature 142 configured to retain thecontact member 106 relative to the push member 102 until a certainpre-designed axial force is exceeded. After the pre-designed force isexceeded, the contact member 106 may move further axially into the pushmember 102. For example, first pre-insertion lock feature 142 can beconfigured to extend into a second pre-insertion lock feature 144, suchas a window shown or groove formed in push member 102 so as to preventpush member 102 from sliding over contact member 106 prior to insertion,as described below with reference to FIGS. 2A-2F. However, after thepre-designed force is overcome through application of an axial force Fby the user on the push member 102, the first pre-insertion lock feature142 can flex and move axially inside and along the inner surface of thepush member 102 so that relative axial sliding motion of the contactmember 106 into the push member 102 is allowed. First pre-insertion lockfeature 142 may be a spring tab including a hook or the like seated inthe groove or slot as shown in FIG. 1E. Once the pre-designed force isovercome, the axial force F may vary slightly over the remainder of thestroke.

FIG. 1F is an exploded, partial cross-sectioned, side-perspective viewof the example biosensor inserter 100 with a portion of outer member 102and inner member 106 removed for illustrative purposes, in accordancewith embodiments provided herein. FIGS. 1F and 1G illustrate an internalguide feature 132 formed on an inside surface of contact member 106along which an end (e.g., planar end 116E-FIG. 1O) of the pivot member116 may axially slide during at least part of the stroke of theinsertion method, as described further herein. The guide feature 132 maybe a planar-bottomed groove slightly wider than a width of the pivotmember 116. The guide feature 132 may intersect with the latch 109 (FIG.1G), at its lower end. Internal guide feature 132 may beaxially-disposed and receive the end 116E of the pivot member 116 andrestrain rotation of the pivot member 116 over the first portion of thestroke, wherein rather than rotate, the end 116E slides vertically alongthe guide feature 132 and is restrained from rotation. Note that othertypes of the internal guide feature 132 may be used. For example, innermember 106 may have a protruding alignment feature such as a ribreceived in a groove formed in the end of the pivot member 116 forguiding pivot member 116.

With further reference to FIG. 1D, transmitter carrier 114 may be formedfrom a cylindrical body that includes a base 134, which is used tosupport the transmitter and sensor assembly 115 during insertion (asdescribed further herein). The base 134 also couples to supportingstructure, which is configured to support the pivot member 116. As bestshown in FIGS. 1J-1K, supporting structure may include the first support135 having a first guide 135G and a second support 136 having a secondguide 136G. Guides 135G and 136G may comprise slots that can be axiallyoriented and extending and may be employed to guide the insertion device120 (FIGS. 1S-1U) during the insertion method, as described furtherherein. Insertion device 120 slides into insertion device supportfeature 139 of pivot member 116 (e.g., into the fork 139F), and alsointo guides 135G and 136G of first and second side supports 135 and 136straddling the pivot member 116.

As best shown in FIG. 1D, push element 104 may extend downward from theunderside 121U of the top portion 121 and may include a contact end104C. Push element 104 may be substantially rigid and may extendgenerally perpendicularly from the underside 121U, and may be offset, asshown, from the axial axis 105. Push element 104 may include a contactend 104C that contacts, and pushes on, the pivot member 116 during theinsertion method. In some embodiments, contact end 104C may include acylindrical end portion that contacts the push element interface feature140 (e.g., a pocket as shown in FIG. 1L, for example). During insertion,the push element 104 does not bend or deform in any substantial way, sothat pushing on the push member 102 telescopes the contact member 106within the push member 102 and linearly translates both the pivot member116 and the transmitter carrier 114 towards the user's skin 113 duringthe insertion portion of the stroke.

Example dimensions of push element 104 range from about 25 mm to 35 mmlong, 5 mm to 15 mm wide, and 3 mm to 10 mm thick. Other dimensions maybe used. Example materials for push element 104 and pivot member 116include acrylonitrile butadiene styrene (ABS), polycarbonate, nylon,acetal, polyphthalamide (PPA), polysulfone, polyethersulfone,polyetheretherketone (peek), polypropylene, high-density polyethylene(HDPE), and low-density polyethelene (LDPE). Other materials may beused.

Assembly and operation (the insertion method) of the biosensor inserter100 is now described with reference to FIGS. 2A-2F, which illustrateside cross-sectional views of the biosensor inserter 100 during theinsertion method of a biosensor 150 in accordance with embodimentsprovided herein.

To assemble the biosensor inserter 100, the transmitter-insertionassembly 119 made up of the transmitter and sensor assembly 115 (FIGS.1Q-1R) with insertion device 120 (FIGS. 1S-1V) is inserted from thebottom so that body 120B of the insertion device 120 passes throughaperture 145 (FIG. 1I), up through slot ends 146, and into guides 135G,136G in the transmitter carrier 114, along a path shown by dotted arrow146 in FIG. 1J. Thus, the ends of legs 120L are received in the slotends 146 and transition up and to the right in FIG. 1J into enter theguides 135G, 136G. Once the transmitter-insertion assembly 119 oftransmitter and sensor assembly 115 and insertion device 120 is properlypositioned in the guides 135G, 136G, it may be held in place in thetransmitter carrier 114 with any suitable quick release feature, such asa slight interference fit within the recess 118 (see FIG. 1D), orpossibly a small amount of double sided adhesive tape or suitablelow-strength adhesive.

Next, the fork 139F (FIG. 1M) of the insertion device support feature139 of the pivot member 116 is received over the legs 120L and thelaterally-extending features 125 of the pivot member 116 are snappedinto the holes 127 in the side supports 135, 136 to form the pivotaligned with pivot axis 125A.

Next, the carrier assembly 137 (FIG. 1M) made up of transmitter carrier114 with the pivot member 116, insertion member 120, and the transmitterand sensor assembly 115 are inserted into contact member 106 as shown inFIG. 1L to form subassembly 141. The carrier assembly 137 can beinserted into the bottom of the contact member 106 until the first stopfeature 148 (FIGS. 1I-1J) of the transmitter carrier 114 contacts one ormore second stop features 151 formed at the end of the cutout portion106C of the contact member 106 (See FIGS. 1G and 1H). Other suitablestop features may be used to limit the extent that the carrier assembly137 can be inserted into the contact member 106. A slight interferencefit may be provided between the outside surface of the carrier assembly137 and the inside surface of the contact member 106 to retain theassembly 137 inside of the contact member 106.

Next, some or all of push member 102 can be installed over thesubassembly 141 (FIG. 1L) as shown in FIG. 1D. The push member 102 canbe installed by first installing the bottom portion 102B over thesubassembly 141 until the first pre-insertion lock feature 142 snapsinto the second pre-insertion feature 144. First pre-insertion lockfeature 142 can be a snap-fit hook and the second pre-insertion feature144 can be a slot or groove, for example.

Next, the top portion 102T can be installed over the over the bottomportion 102B. Upon proper alignment, the two or more spring tabs 108each including an inward protuberance 108P can be seated in therespective retaining features 108R. Upon installation, the push element104 is aligned with, and in close proximity to or just touching, thepush element interface feature 140 of the pivot member 116. As shown,contact member 106 is sized to fit within push member 102, and may havea close sliding fit or even a slight interference fit, for example.

Now referring to FIGS. 1D, 1I, 1J, and 1U, insertion device 120 has amain body portion 120B that resides within insertion device supportfeature 139 (e.g., fork 139F) of pivot member 116, and an insertionportion 120I that is extendable from the transmitter carrier 114 throughan aperture 145 (FIG. 1I) in the base 134 of transmitter carrier 114.Insertion portion 120I of insertion device 120 can have a sharpened end(FIG. 1U) that pierces the user's skin 113 (FIGS. 2A-2F) to introduce abiosensor 150 into a subcutaneous region 113S of a user as describedfurther herein. Insertion portion 120I also may be referred to as aninsertion shaft, needle, trocar, sharp or the like. Upon retraction ofthe insertion portion 120I, the biosensor 150 received in an opening150O (slot, elongated cavity, or groove as shown, for example, in FIGS.1U and 1V) formed along a length of the insertion portion 120I remainsin the subcutaneous region 113S of the user.

In some embodiments, aperture 145 in the base 134 of transmitter carrier114 is positioned and/or centered below guides 135G, 136G of first andsecond supports 135 and 136 such that insertion portion 120I remainsapproximately vertical during insertion (and/or approximatelyperpendicular to a region into which the insertion portion 120I is to beinserted), as shown in FIG. 2A. Body portion 120B of the insertiondevice 120 may include a flange 120F (FIGS. 1S-1V) that may interfacewith a top surface of the transmitter and sensor assembly 115 so as toact as an alignment guide to help provide the approximatelyperpendicular orientation of the insertion portion 120I to thetransmitter.

Insertion portion 120I of insertion device 120 may be made, for example,from a metal such as stainless steel, or a non-metal such as plastic.Other suitable materials may be used. In some embodiments, insertionportion 120I of insertion device 120 may be, but is not limited to, around C-channel tube, a round U-channel tube, a stamped sheet metal partfolded into a U-profile in cross-section, a molded/cast metal part witha U-channel profile in cross-section, or a solid metal cylinder with anetched or ground channel causing a U-shapes cross-section. Otherinsertion portion shapes may be used that allow insertion andretraction, while leaving behind the implanted biosensor 150.

Main body portion 120B of insertion device 120 may be formed from aplastic, for example, such as, but not limited to, acrylonitrilebutadiene styrene (ABS), polycarbonate, nylon, acetal, polyphthalamide(PPA), polysulfone, polyethersulfone, polyetheretherketone (peek),polypropylene, high-density polyethylene (HDPE), and low-densitypolyethelene (LDPE). Other materials may be used.

As best shown in FIG. 1U and 1V, the biosensor 150 is received in theopening 150O of the insertion portion 120I, extends along the length ofthe insertion portion 120I, transitions into a passage 152 formed in thethreaded portion 102T, and then passes laterally out of passage 152 toconnect to a connector, an electronic panelboard or other likeelectronic component 154 including or coupled or configured to couple toa transmitter electronics of the transmitter and sensor assembly 115.Thus, upon insertion and then retraction of the insertion portion 120Iin and from the user's skin 113, the biosensor 150 can remain in placeby being removed from passage 152 and the opening 150O.

Operation of biosensor inserter 100 is now described with reference toFIGS. 2A-2F and FIG. 3, which illustrates a flowchart of a method 300 ofusing a biosensor inserter 100 to insert a biosensor 150 in accordancewith embodiments provided herein.

In operation, the transmitter and sensor assembly 115 (shown dotted inFIGS. 2A-2F) can be detachably coupled to the transmitter carrier 114and may be positioned within the recess 118 in the lower region oftransmitter carrier 114, in some embodiments. Transmitter and sensorassembly 115 includes an adhesive layer to adhere the transmitter andsensor assembly 115 to the user's skin 113 upon retraction of theinsertion device 120. However, as should be apparent, a recess isoptional, and the transmitter and sensor assembly 115 may be simplydetachably mounted to the lower region of the transmitter carrier by anysuitable means.

To begin the insertion method 300 of FIG. 3, the needle cover 124 isremoved from insertion portion 120I of insertion device 120 and thecontact member 106 of the biosensor inserter 100 is placed in contactwith the skin 113 surrounding an insertion site 110 of a user, such ason an upper arm, an abdomen region, or another suitable location toavoid insertion into muscle. This is shown in FIG. 2A.

To begin insertion, a force F is applied to the push member 102 by auser so as to cause the push member 102 to slide over the contact member106 and move toward the insertion site 110. Movement of push member 102over contact member 106 causes push element 104 to contact the pushelement interface feature 140 [See also FIGS. 1N-1P] of pivot member116, which causes transmitter carrier 114 and pivot member 116 totranslate and move toward the insertion site 110, as shown in FIG. 2B,with the latch end 117 moving linearly relative to and toward the latch109 of contact member 106, while end 116E slides along guide feature132.

Such axial movement is allowed after the applied force F is sufficientto cause first pre-insertion lock feature 142 (e.g., hook as shown inFIG. 1A) to flex inward, and out of pre-insertion lock feature 144(e.g., slot or groove) of push member 102, according to the insertionmethod 300. During this first portion of the stroke of the insertionmethod 300, pivot member 116 is prevented from pivoting via contact ofend 116E with the wall surface (e.g., inner guide groove 132) of thecontact member 106, as transmitter carrier 114 and pivot member 116translate toward the insertion site 110.

As shown in FIG. 2C, transmitter carrier 114 and pivot member 116continue to move toward the insertion site 110 until insertion portion120I makes contact and enters insertion site 110, and a bottom surfaceof transmitter and sensor assembly 115 contacts the skin 113 around theinsertion site 110. In some embodiments, bottom surface of transmitterand sensor assembly 115 may adhere (e.g., via an adhesive material) tothe user's skin 113 surrounding the insertion site 110. The insertionportion 120I and biosensor 150 enters the insertion site 110 wherebiosensor 150 can make contact with interstitial fluid in thesubcutaneous region 113S. The biosensor 150 can be placed 4 mm to 6 mminto the skin 113, for example, although other depths may be used.

As shown in FIG. 2C, end 116E of pivot member 116 remains in contactwith the inner surface (e.g., guide surface 132 of latch 109) of innermember 106 and is prevented from pivoting in the first portion of thestroke. Thus, during insertion of the biosensor 150, the pivot member116 is prevented from pivoting. This causes insertion portion 120I toremain in a fixed position relative to the pivot member 116 andtransmitter carrier 114, with flange 120F against the top surface of thetransmitter and sensor assembly 115.

As shown in FIG. 2D, following insertion of the biosensor 150 (and/oradhesion of the transmitter and sensor assembly 115 to the skin 113around the insertion site 110), the outer member 102 continues to moveover the inner member 106 toward the insertion site 110 in a secondportion of the stroke. When the latch end 117 of the pivot member 116moves past the latch 109 at the start of the second portion of thestroke, the pivot member 116 is allowed to pivot via the pushing by pushelement 104, rotate under latch 109 and into cutout portion 106C. Thepivoting causes the retraction of the insertion device 120 in the secondportion of the stroke.

During the retraction, pivot member 116 pivots on the transmittercarrier 114 due to the force applied by push element 104 on pivot member116 (as shown in FIG. 2D). As this occurs, insertion portion 120I ofinsertion device 120 retracts from the insertion site 110 and flange120F moves away from transmitter and sensor assembly 115. As the outermember 102 continues to move over the inner member 106 toward theinsertion site 110, push element 104 continues to press against pivotmember 116. Eventually, as shown in FIG. 2F, pivot member 116 pivotssufficiently for insertion device 120 to be completely removed from theuser's skin 113 and leave the implanted biosensor 150 therein. As thepush member 102 is pushed further, the insertion device 120 is retractedfully above the aperture 145. As such, insertion portion 120I ofinsertion device 120 cannot inadvertently be reinserted into insertionsite 110. Additionally, as push member 102 continues to move towardinsertion site 110, after insertion, an axial stop feature 155 (FIG. 1Jand FIG. 2F) of transmitter carrier 114 can contact pivot member 116 andprevent insertion device 120 from retracting further.

Biosensor inserter 100 then may be removed, leaving transmitter andsensor assembly 114 in place, with the bottom surface of transmitter andsensor assembly 115 adhered to the user's skin 113 at the insertion site110 and biosensor 150 in contact with interstitial fluid (as shown inFIG. 2F). In some embodiments, in which the push member 102 and/orcontact member 106 are formed of recyclable or biodegradable material,these components may be recycled or composted.

Referring now to FIG. 3, an embodiment of a method 300 of using abiosensor inserter (e.g., biosensor inserter 100) to insert a biosensor(biosensor 150) is described. The method 300 comprises, in block 302,providing the biosensor inserter 100 comprising: a push member (e.g.,push member 102) including a push element (e.g., push element 104), acontact member (e.g., contact member 106) translatable relative to thepush member, the contact member including a latch (e.g., latch 109), atransmitter carrier (e.g., transmitter carrier 114) translatablerelative to the contact member and configured to support a transmitterand sensor assembly (e.g., transmitter and sensor assembly 115) duringinsertion of the biosensor (e.g., biosensor 150), a pivot member (e.g.,pivot member 116) configured to pivot relative to the transmittercarrier, the pivot member including a latch end (e.g., latch end 117),and an insertion device 120 (insertion device 120) drivable by the pivotmember.

The method 300 further comprises, in block 304, contacting the contactmember (e.g., contact member 106) to a user's skin (e.g., skin 113 asshown in FIG. 2A). The contacting is followed by pushing, in block 306,on the push member 102 (e.g., push member 102) to cause the push element104 to contact the pivot member 116 (e.g., at push element interfacefeature 140, such as a pocket), translate the transmitter carrier (e.g.,axially translate the transmitter carrier 114 within the contact member106), and insert the insertion device (e.g., the insertion portion 120Iof the insertion device 120) and biosensor 150 through the user's skin113, wherein the pivot member (e.g., pivot member 116) is prevented frompivoting. In particular, pivot member (e.g., pivot member 116) isprevented from pivoting over a first portion of the stroke.

The method 300 further comprises, in block 308, continuing to push thepush member (e.g., push member 102) until delatching of the latch end(e.g., latch end 117) from the latch (e.g., latch 109 of the contactmember 106) occurs, wherein the pivot member 116 is allowed to pivot andretract the insertion device 120, while leaving the biosensor 150implanted in the user's skin 113. Delatching occurs after the firstportion of the stroke when the latch end 117, as a result of the pushingof pivot member 116 by push element 104, moves beyond the latch 109 andcan rotate underneath the latch 109. The pivoting of the pivot member116 in a second portion of the stroke of the push member 102 operativelyretracts the insertion portion 120I of the insertion device 120 from theuser's skin 113 and leaves behind the implanted sensor 150.

FIGS. 4A and 4B illustrate an alternative embodiment of the biosensorinserter 400. This embodiment has several features that are advantagedergonomically and/or functionally as compared to thepreviously-described embodiments herein. In particular, the overallshape, including the shape of the push member 402 and the contact member406 are elongated in lateral cross-section as compared to the roundshape of the embodiments of the biosensor inserter 100 shown in FIGS.1A-1C. This elongated shape allows for a more ergonomically-secure graspof the push member 402. Moreover, given that the transmitter and sensorassembly 115 (not shown in FIG. 4B) tends to be made up of rectangularcircuitry components, an elongated shape can offer a more compactoverall configuration. To further improve the ergonomic grasping of thepush member 404, the insertion device 400 can comprise a plurality ofribs 454 that extend circumferentially around the upper perimeter ofpush member 402. As shown, ribs 454 can extend greater than 150 degreesaround the top portion of the push member 402. Like ribs 454 areprovided on the opposite side of the push member 402. As shown, threeribs are formed via molding on either side and extend circumferentiallyaround the perimeter of the push member 402 and connect with end ribs455A, 455B. The end ribs 455A, 455B can be aligned with the verticaldirection as shown. The height of the ribs 454 may be different so toprovide an arcuate vertical grasping profile as best shown beingconfigured on end ribs 455A, 455B. The height of the ribs 454 may rangefrom 1 mm to 3 mm for each rib 454, for example. The width of the ribs454 may range from 1 mm to 5 mm, for example.

Now referring to FIGS. 4A-4B and 5C, an alternate embodiment of acontact member 406 is provided that can include a peripheral flange 458.The peripheral flange 458 can extend outwardly from some or all of abody portion 406B of the contact member 406. As best shown in FIG. 4B,the peripheral flange 458 can extend outwardly by a width W measuredalong a plane of the flange 458 from an inner edge 458 i to an outeredge 458 o. Width W can be greater than or equal to 5 mm at leastpartway around the periphery, wherein W is a width of the peripheralflange 458. In some embodiments, the peripheral flange 458 may extendfully around the circumferential periphery, and may have a width Wgreater than or equal to 5 mm at all locations. The inner edge 458 i mayinclude some recesses and protuberances for engaging with thetransmitter carrier 414. In some embodiments, the contact member 406with the peripheral flange 458 can have Ac≥500 mm², wherein Ac is acontact area of the peripheral flange 458 that is configured to contacta user's skin during insertion of the biosensor.

Referring now to FIGS. 5A and 5B, the push element 504 extending fromthe underside 521U of the push member 402 can include a T-shaped crosssection along at least a portion of its length as best shown in FIG. 5Bto provide enhanced rigidity yet a thinner profile for less moldingissues. The push element 504 can include a main portion 504M including acontact end 504C that may include a cylindrical end configuration thatcontacts a push element interface feature (e.g., a pocket 640 of pivotmember 616 as shown in FIG. 6B, for example). Push member 402 can alsoinclude support portion 504S, which coupled to the main portion 504M,such as at a right angle thereto to form the T-shaped cross section.Support portion 504S may be somewhat shorter than the main portion 504Mso that the contact end 504C does not impede rotation in the pocket 640as the pivot member 616 rotates. Push member 402 may include draftangles on all surfaces to allow for improved removal from the mold.

Now referring to FIGS. 6A-6B, an alternative embodiment of a transmittercarrier 614 is shown that comprises a plurality of fins 660 configuredto be received and slide within vertical slots 562 formed in the contactmember 406. As shown, there are four of the fins 660. Respective pairsof the fins 660 can lie in a same vertical plane. Each of the fins 660is made up of a vertical connector 662 extending from a base 664. Eachof the vertical connectors 662 connects to a paddle 665 that extendsupwardly and laterally outward from the connector 662, wherein theoutermost part of the paddles 665 are received in and register withinthe vertical slots 562.

Further, in the depicted embodiment of FIGS. 6A-6B, the transmittercarrier 614 comprises closed guide grooves 635, 636 configured toreceive legs 620L of the insertion device 620 as shown in FIGS. 6C and6D. The closed guide grooves 635, 636 include open portions facing eachother and the groves extend vertically as shown and have a shape thatguides the insertion device 620 during both insertion and retraction.Each of the closed guide groves 635, 636 have a closed portion oppositethe open portion and positioned adjacent to the ends of the legs 620L ofthe insertion device 620.

As shown in FIGS. 6C and 6D, the insertion device 620 includes a mainbody 620B made of a polymer material, such as, but not limited to,acrylonitrile butadiene styrene (ABS), polycarbonate, nylon, acetal,polyphthalamide (PPA), polysulfone, polyethersulfone,polyetheretherketone (peek), polypropylene, high-density polyethylene(HDPE), and low-density polyethelene (LDPE), and an insertion needle660I, which may be stainless steel or the like. Other suitable materialcould be used. Main body 620B includes legs 620L extending from lateralsides, wherein the legs 620L are received in the closed guide grooves635, 636 (FIGS. 6A-6B). Main body 620B includes recess 620R that issized to receive a transverse portion 620T of the insertion needle 660I,and a hole (not shown) through registration portion 661 that receivesthe sensor carrying portion 620S there through. Once inserted, anadhesive or potting compound can be used to secure the transverseportion 620T of the insertion needle 620I into the recess 620R, and thussecure the insertion needle 620I to the main body 620B.

FIG. 7 illustrates an exploded view of the various components of thebiosensor inserter 400. As shown, are the push member 402 that isconfigured to be securely grasped by the user, the pivot member 416,which pivots to accomplish retraction of the insertion device 620 afterinsertion of the biosensor, the first and second parts of thetransmitter carrier 414A, 414B, the insertion device 620, and thecontact member 406 with laterally-extending peripheral flange 458.

The foregoing description discloses only example embodiments.Modifications of the above-disclosed apparatus and methods, which fallwithin the scope of this disclosure, will be readily apparent to thoseof ordinary skill in the art.

What is claimed is:
 1. A biosensor inserter, comprising: a push memberincluding a push element; a contact member translatable relative to thepush member, the contact member including a latch; a transmitter carriertranslatable relative to the contact member and configured to support atransmitter and sensor assembly during insertion of a biosensor; and apivot member configured to pivot on the transmitter carrier, the pivotmember including a latch end; and an insertion device drivable by thepivot member to insert the biosensor, wherein during insertion of thebiosensor in a first portion of a stroke, the pivot member is preventedfrom pivoting, and wherein when the latch end of the pivot member movespast the latch, the pivot member is allowed to pivot in a second portionof the stroke and retract the insertion device.
 2. The biosensorinserter of claim 1 wherein the push member includes a top member and abottom member, wherein the bottom member is coupled to the top member,and the bottom member comprises a sleeve and the top member comprises aninverted cup receivable over the sleeve.
 3. The biosensor inserter ofclaim 1 wherein the push member includes a first alignment feature andthe contact member includes a second alignment feature, and wherein thefirst alignment feature is configured to interface with the secondalignment feature so as to vertically align the latch end with thelatch.
 4. The biosensor inserter of claim 1 wherein the push element isconfigured as a rigid post.
 5. The biosensor inserter of claim 1 whereinthe push element is configured as a rigid post extending perpendicularlyfrom an underside surface of a top portion of a top member.
 6. Thebiosensor inserter of claim 1 wherein the push member comprises aninverted cup and the inverted cup comprises a top portion and an annularsleeve portion.
 7. The biosensor inserter of claim 1 wherein the pushmember comprises a ramp proximate a lower end thereof, and the contactmember includes a first pre-insertion lock feature configured to engagewith the ramp upon assembly.
 8. The biosensor inserter of claim 1wherein the push member includes a first pre-insertion lock feature, andthe contact member includes a second pre-insertion lock featureconfigured to engage with the first pre-insertion lock feature.
 9. Thebiosensor inserter of claim 1 wherein the contact member comprises avertically-extending cutout.
 10. The biosensor inserter of claim 1wherein the contact member comprises an internal guide feature that isconfigured to interface with the latch end of the pivot member.
 11. Thebiosensor inserter of claim 10 wherein the internal guide featurecomprises an inside groove.
 12. The biosensor inserter of claim 1wherein the transmitter carrier comprises a limit stop featureconfigured to stop pivoting of the pivot member.
 13. The biosensorinserter of claim 1 wherein the transmitter carrier comprises a base andside supports disposed thereon, and the side supports comprise a firstguide and a second guide configured to guide the insertion device. 14.The biosensor inserter of claim 1 wherein the pivot member includes aninsertion device support feature configured to support the insertiondevice during the insertion.
 15. The biosensor inserter of claim 14wherein the insertion device support feature comprises a fork configuredto receive legs of a body of the insertion device therein.
 16. Thebiosensor inserter of claim 1 wherein the pivot member includes a pushelement interface feature comprising a pocket configured to interfacewith a contact end of the push element.
 17. The biosensor inserter ofclaim 1 wherein the insertion device includes a body portion and aninsertion portion, wherein the body portion comprises legs configured tointerface with a fork of an insertion device support feature of thepivot member.
 18. The biosensor inserter of claim 1 wherein theinsertion device comprises a detachable needle cover.
 19. The biosensorinserter of claim 1 wherein the insertion device comprises a ribsextending circumferentially around the push member.
 20. The biosensorinserter of claim 1 wherein the contact member comprises a peripheralflange extending outwardly from an inner edge to an outer edge of W≥5mm, the peripheral flange extending at least partway around a periphery,wherein W is a width of the peripheral flange.
 21. The biosensorinserter of claim 1 wherein the contact member comprises a peripheralflange having Ac≥500 mm², wherein Ac is a contact area of the peripheralflange that is configured to contact a user's skin during insertion. 22.The biosensor inserter of claim 1 wherein the transmitter carriercomprises a plurality of fins, wherein each fin is configured to bereceived in a vertical slot formed in the contact member.
 23. Thebiosensor inserter of claim 22 comprising four of the fins wherein pairsof the fins lie in a same plane.
 24. The biosensor inserter of claim 22wherein each of the plurality of fins is each made up of a verticalconnector connecting to a paddle extending upward and laterally outwardfrom the vertical connector, wherein an outermost part of the paddle isreceived in and registers within the vertical slot.
 25. The biosensorinserter of claim 1 wherein the transmitter carrier comprises closedguide grooves configured to receive legs of the insertion device.
 26. Abiosensor inserter configured to insert a biosensor of a continuousmonitoring transmitter and sensor assembly, comprising: a push memberhaving a rigid push element and a first alignment feature; a contactmember having a latch and a second alignment feature, the contact memberconfigured to telescope within the push member; a transmitter carrierconfigured to support the continuous monitoring transmitter and sensorassembly during insertion of the biosensor; a pivot member configured topivot on the transmitter carrier, the pivot member including a latchend, and an insertion device supported by the pivot member; and whereinthe first alignment feature of the push member is configured tointerface with the second alignment feature of the contact member so asto align latch end with the latch, and wherein the pivot member isconfigured to slide relative to an internal guide feature of the contactmember and the pivot member is prevented from pivoting in a firstportion of a stroke during insertion of the biosensor, and wherein whenthe latch end of the pivot member moves past the latch, the pivot memberis allowed to pivot in a second portion of the stroke and retract theinsertion device leaving the biosensor implanted.
 27. A method of usinga biosensor inserter to insert a biosensor, comprising: providing thebiosensor inserter comprising: a push member including a push element, acontact member translatable relative to the push member, the contactmember including a latch, a transmitter carrier translatable relative tothe contact member and configured to support a transmitter and sensorassembly during insertion of the biosensor, a pivot member configured topivot relative to the transmitter carrier, the pivot member including alatch end, and an insertion device drivable by the pivot member;contacting the contact member to a user's skin; pushing on the pushmember during a first portion of a stroke to cause the push element tocontact the pivot member, translate the transmitter carrier, and insertthe insertion device and biosensor through and into the user's skin,wherein the pivot member is prevented from pivoting during the firstportion of the stroke; and continuing to push the push member untildelatching of the latch end from the latch, wherein the pivot member isallowed to pivot during a second portion of the stroke and retract theinsertion device while leaving the biosensor implanted.